ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol

The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.

Government Updates Medical Device Classification Lists, Seeks Public Feedback

Drafts of the revised classification lists are available for public review. Stakeholders, including industry associations and medical professionals, are encouraged to provide feedback through the dedicated Google Form by February 5, 2025. Following the feedback period, the CLA will finalize and publish the updated classification lists.

ICMR and CDSCO Seek Public Input on Draft Protocols For Standardizing IVD Testing

ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools. ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025.

Government Seeks Public Input on New Standards for Clinical Electrical Thermometers

The proposed rules mandate verification and stamping of clinical electrical thermometers to ensure compliance with the new standards. These thermometers, used in homes, hospitals, and various industries, play a vital role in diagnosing fevers, hypothermia, and other temperature-related conditions. This additional measure strengthens consumer protection and promotes trust in the devices.

Government Ramps Up Production of Pharmaceuticals and Medical Devices in India

The PLI scheme for Bulk Drugs, with a financial outlay of Rs. 6,940 crore, incentivizes the manufacturing of essential Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). With a budget of Rs. 15,000 crore, the PLI Scheme for Pharmaceuticals focuses on high-value products like patented/off-patented drugs, biopharmaceuticals, complex generics, and anti-cancer drugs. The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices targets high-end medical devices previously imported into India.

BIS Drives Innovation In Medical Device Standards

In alignment with the National Medical Device Policy, 2023, BIS has identified 214 critical medical devices for standardization. This includes lifesaving devices like cardiac pacemakers, ventilators, and haemodialysis machines, as well as advanced diagnostic tools such as X-ray machines, CT scanners, and MRI systems.

Introducing A Scheme for Strengthening The Medical Device Industry

The scheme, with a total outlay of Rs 500 crore, targets critical areas such as manufacturing, skill development, and clinical studies. The new scheme is expected to further accelerate the growth of the industry and position India as a global leader in medical device manufacturing.

New Recruitment Rules for Medical Device Regulatory Positions

The rules specify the number, classification, and pay level for various medical device regulatory positions. The method of recruitment, age limit, qualifications, and other eligibility criteria for each post are also outlined. Existing employees in relevant positions will be deemed to have been appointed under these new rules.